US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials | Zendy

Marianne Razavi | Zendy; Paul Glasziou | Zendy; Farina Klocksieben | Zendy; John P. A. Ioannidis | Zendy; Iain Chalmers | Zendy; Benjamin Djulbegović | Zendy

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US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials

Author(s) -

Marianne Razavi,

Paul Glasziou,

Farina Klocksieben,

John P. A. Ioannidis,

Iain Chalmers,

Benjamin Djulbegović

Publication year - 2019

Publication title -

jama network open

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.278

H-Index - 39

ISSN - 2574-3805

DOI - 10.1001/jamanetworkopen.2019.11111

Subject(s) - medicine , food and drug administration , clinical trial , randomized controlled trial , odds ratio , odds , drug , clinical research , off label use , medline , psychological intervention , pharmacology , logistic regression , political science , law , psychiatry

In this study, estimated magnitudes of effect were larger among studies for which the FDA did not require RCTs compared with studies for which it did. There was no clear threshold of treatment effect above which no RCTs were requested.

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